BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS DX¿ STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 1994041 · Received February 16, 2011

    Report

    Report Number
    3001236349-2011-00005
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DRF
    PMA / PMN Number
    K924163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT HAD NO CONSEQUENCES TO PATIENT AND/OR NO PATIENT COMPLICATIONS. THE CATHETER WAS NOT USED IN THE PROCEDURE AND ANOTHER SIMILAR DEVICE WAS OPENED TO FINISHED THE PROCEDURE. THE REPORTED CATHETER IS EXPECTED TO BE RETURNED AND WILL BE EVALUATED. EVALUATION SUMMARY WILL BE SUBMITTED. DEVICE NOT YET RECEIVED

    Description of Event or Problem · 1

    BSC SALES REPRESENTATIVE REPORTED ON (B)(6) 2011 THAT "THE WIRES ON POLARIS DX CATHETER WERE EXPOSED WHEN THEY OPENED THE CATHETER. IT WAS NEVER USED IN THE CASE. THEY USED ANOTHER POLARIS DX CATHETER TO COMPLETE THE PROCEDURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS DX¿ STEERABLE DIAGNOSTIC CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC M0045574S0 13891836

    Patients

    Seq Age Sex Outcome Treatment
    1